BIOMA 5000

FDA 510(k)

FDA Class 2 ·Cardiovascular

TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU

FDA 510(k)

FDA Class 2 ·Neurology

PSL BIOZIR BLOCK

FDA 510(k)

FDA Class 2 ·Dental

OTIS Optical Coherence Tomography SYstem

FDA 510(k)

FDA Class 2 ·Radiology

BresoDX1

FDA 510(k)

FDA Class 2 ·Anesthesiology

INSITE FILTER & TUBING SET

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BRIGHTMATTER PLANNING SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology

Halifax Imaging Kit

FDA 510(k)

FDA Class 2 ·Radiology

Z0174, IMPEDANCE AUDIOMETER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SnapshotGLO (KB100)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HAEMODIALYSIS CONCENTRATE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FORTEC MI-100, BLOOD PRESSURE METER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Natus Brain Monitor Amplifier

FDA 510(k)

FDA Class 2 ·Neurology

IROOT FS

FDA 510(k)

FDA Class 2 ·Dental

HINGE PEDIATRIC PLATING SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C

FDA 510(k)

FDA Class 2 ·General Hospital

IGAR System (1001.A)

FDA 510(k)

FDA Class 2 ·Radiology

ROSA® Knee System

FDA 510(k)

FDA Class 2 ·Neurology

MolecuLightDX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OMNIgene GUT Dx

FDA 510(k)

FDA Class 2 ·Microbiology